This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess
MEDDEV 2.12-1 Guidelines on Medical Devices Vigilance System Updated to Rev 8
This blog post is thx to our associate Christine Ruther and a special thx goes out to Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013. The revised guidance is applicable as of July
NB-MED issues FAQ on Implementation of EN62304:2006 w.r.t. MDD, V1.0
18 April 2013 – The NB-MED EN62304:2006 issues team released their first official version (V1.0) dated 5 April 2013 of this importnat implementation document in regards to EN 62304 with respect to the Medical Device Directive 93/42/EEC on the NB-MED website. EN
New LinkedIn Group on IEC 60601 Medical Electrical Equipment & Systems
A new LinkedIn group has been formed thx to the support of the IEC (International Electrotechnical Commission)*. The group name is the IEC 60601 series of standards on Medical Electrical Equipment. This group is not just about the 3rd edition
Proposed Changes to EU Data Protection Directive – May Impact Device Design
Erik Vollebregt, of the law firm Axon Lawyers, has written a very insightful blog post on the recent developments of changes to come down the line for the EU Data Protection Directive and it looks likely that it will turn